FDA applicant
Norav Medical, Ltd.
FDA records 6 decisions for Norav Medical, Ltd. (Mitzpe Aviv, IL) from 2000 to 2016: 6 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and MLO (Electrocardiograph, Ambulatory, With Analysis…). Its devices cite 3 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Norav Medical GmbH”, “Norav Medical Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Norav Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Norav Medical, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report